Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421935
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors DDRiver 501
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
Official Title:
An Open Label Multicenter Phase 1 Study to Evaluate the Safety Tolerability and PharmacokineticPharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Solid Tumors DDRiver 501
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety tolerability pharmacokinetics pharmacodynamic and preliminary clinical activity of M9466 as monotherapy or in combination with tuvusertib in participants with advanced solid tumors Study details include StudyTreatment Duration Participants will be treated until disease progression death discontinuation or End of Study Visit Frequency Every week in the first 2 cycles followed by every 3 weeks in the subsequent cycles An End of Treatment Visit and Safety Follow-upDiscontinuation Visit are scheduled after the treatment period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-513492-41-00 | OTHER | EU CTR | None |